FDA Product Code
FDA Product Code MBI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3040
510(k) Clearances — 604 records · page 2 of 7
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K232005 | HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue); HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue Cobraid) | Smith & Nephew, Inc. | 2023-08-04 | Special | PDF ↗ |
| K231404 | T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open Button | Healthium Medtech Limited | 2023-08-04 | Traditional | PDF ↗ |
| K223114 | Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors | Gm Dos Reis Industria E Comerico Ltda. | 2023-08-02 | Traditional | PDF ↗ |
| K231278 | Knotless Suture Anchor | Riverpoint Medical, LLC | 2023-08-01 | Traditional | PDF ↗ |
| K231002 | Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture anchor, Javelot PK-P suture anchor (Knotless), Javelot PK-L suture anchor (Knotless) | Suzhou Endophix Co., Ltd. | 2023-06-07 | Traditional | PDF ↗ |
| K231322 | Fix2Lock(PEEK Self Punching) | Osteonic Co., Ltd. | 2023-06-07 | Special | PDF ↗ |
| K231330 | FiberTak® Suture Anchor | Arthrex, Inc. | 2023-06-01 | Special | PDF ↗ |
| K230874 | Syntheface PEEK Interference Screw, Syntheface PEEK Screw Sheath | Suzhou Endophix Co., Ltd. | 2023-05-23 | Traditional | PDF ↗ |
| K223860 | Integrity Bone Staple Fixation System | Anika Therapeutics, Inc. | 2023-05-22 | Traditional | PDF ↗ |
| K231113 | Arthrex FiberTak Suture Anchor | Arthrex, Inc. | 2023-05-18 | Special | PDF ↗ |
| K231128 | JuggerKnot Soft Anchor | Riverpoint Medical, LLC | 2023-05-17 | Special | PDF ↗ |
| K230655 | PEEK RCI Screw; Bio-Composite Screw; SignaLoc Screw | Signature Orthopaedics Pty, Ltd. | 2023-05-03 | Traditional | PDF ↗ |
| K230123 | Apollo Knotless Suture Anchor | Maruho Medical | 2023-05-03 | Traditional | PDF ↗ |
| K230544 | SnugFit All-Suture Anchor extension | Medacta International S.A. | 2023-04-17 | Special | PDF ↗ |
| K230568 | FiberTak Suture Anchor | Arthrex, Inc. | 2023-04-01 | Special | PDF ↗ |
| K222423 | Fixone All Suture Anchor | Aju Pharm Co., Ltd. | 2023-03-23 | Special | PDF ↗ |
| K220464 | Tigon Medical Gryphon Anchor Line | Tigon Medical | 2023-03-22 | Traditional | PDF ↗ |
| K223889 | Stativ® Knotted UHMWPE Suture Anchor | Healthium Medtech Limited | 2023-03-22 | Traditional | PDF ↗ |
| K223878 | Aevumed RAPID Suture Anchors | Aevumed, Inc. | 2023-03-17 | Traditional | PDF ↗ |
| K230433 | Arthrex Knotless FiberTak Suture Anchor | Arthrex, Inc. | 2023-03-10 | Special | PDF ↗ |
| K220966 | SINEFIX | BAAT Medical Products B.V. | 2023-03-08 | Traditional | PDF ↗ |
| K223589 | Grappler Suture Anchor R3FLEX IOL System | Paragon 28, Inc. | 2023-03-03 | Traditional | PDF ↗ |
| K223582 | MectaLock TI Triple Loaded Suture Anchor | Medacta International S.A. | 2023-02-24 | Traditional | PDF ↗ |
| K230212 | OrthoButton AL | Riverpoint Medical, LLC | 2023-02-23 | Special | PDF ↗ |
| K222971 | ULTRABUTTON QUAD Adjustable Fixation Device; ULTRABUTTON BB Adjustable Fixation Device; ULTRABUTTON TIB SMALL Adjustable Fixation Device; ULTRABUTTON TIB MEDIUM Adjustable Fixation Device; ULTRABUTTON TIB LARGE Adjustable Fixation Device | Smith & Nephew, Inc. | 2023-02-17 | Traditional | PDF ↗ |
| K222574 | Simparo Anchor Line Fixation System | Simparo, Inc. | 2023-02-04 | Traditional | PDF ↗ |
| K223284 | SutureLoc Implant | Arthrex, Inc. | 2023-02-02 | Traditional | PDF ↗ |
| K222589 | Flexible Suturing System with Anchors (FSSA) | Integrity Orthopaedics, Inc. | 2023-01-26 | Traditional | PDF ↗ |
| K223795 | FairFix QT Adjustable Button | Medacta International S.A. | 2023-01-17 | Special | PDF ↗ |
| K221396 | Arthrex FiberTak Suture Anchor | Arthrex, Inc. | 2022-12-22 | Traditional | PDF ↗ |
| K213110 | AUXILOCK PEEK OPTIMA Screw-In Suture Anchor, AUXILOCK ROTADOR PEEK OPTIMA Screw-In Anchor | Auxein Medical Private Limited | 2022-12-16 | Traditional | PDF ↗ |
| K222363 | Aevumed PHANTOM-LP Suture Anchors | Aevumed, Inc. | 2022-11-28 | Traditional | PDF ↗ |
| K213018 | Auxilock GFS Mini, GFS II Large, and GFS Ultimate | Auxein Medical Private Limited | 2022-11-18 | Traditional | PDF ↗ |
| K222763 | Responsive Arthroscopy Mustang and Mustang Knotless Suture Anchors | Responsive Arthroscopy, LLC | 2022-10-13 | Special | PDF ↗ |
| K212197 | WasherCap Fixation System | Abanza Tecnomed S.L | 2022-09-22 | Traditional | PDF ↗ |
| K222091 | Grappler Suture Anchor System | Paragon 28, Inc. | 2022-09-14 | Traditional | PDF ↗ |
| K221731 | FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire | T.A.G. Medical Products Corporation, Ltd. | 2022-09-07 | Traditional | PDF ↗ |
| K213109 | Auxilock Draw Tight Suture-Based Anchor | Auxein Medical Private Limited | 2022-08-22 | Traditional | PDF ↗ |
| K222169 | FairFix Adjustable Button System | Medacta International S.A. | 2022-08-16 | Special | PDF ↗ |
| K222161 | Arthrex Knotless FiberTak Biceps Suture Anchor | Arthrex, Inc. | 2022-08-11 | Special | PDF ↗ |
| K213104 | Auxilock Titanium Screw-In Suture Anchor | Auxein Medical Private Limited | 2022-07-29 | Traditional | PDF ↗ |
| K220901 | S-Core Implant System | Subchondral Solutions, Inc. | 2022-07-29 | Traditional | PDF ↗ |
| K221502 | Parcus Synd-EZ SS | Parcus Medical, LLC | 2022-07-26 | Traditional | PDF ↗ |
| K221364 | Mitek TIGHT-N Anchor | Medos International SARL | 2022-07-11 | Traditional | PDF ↗ |
| K221389 | FairFix AM Adjustable Button FairFix PSP Adjustable Button | Medacta International S.A. | 2022-06-08 | Special | PDF ↗ |
| K221135 | X-Twist PEEK Suture Anchor | Parcus Medical, LLC | 2022-05-19 | Special | PDF ↗ |
| K220757 | Argo Knotless SP Anchor | Conmed Corporation | 2022-05-13 | Traditional | PDF ↗ |
| K220797 | FootHold System | Crossroads Extremity Systems, LLC | 2022-04-15 | Traditional | PDF ↗ |
| K212381 | VersaTap, VersaLat, DueLock, VersaTi, MiniTi | Ortho-Design (Pty), Ltd. | 2021-12-06 | Traditional | PDF ↗ |
| K212739 | ActiFlip | Parcus Medical, LLC | 2021-10-06 | Traditional | PDF ↗ |
| K211322 | Paratrooper Plantar Plate Repair System | Paragon 28, Inc. | 2021-08-30 | Traditional | PDF ↗ |
| K211049 | Tigon Medical Button System | Tigon Medical | 2021-08-04 | Traditional | PDF ↗ |
| K211502 | Alpha Vent PEEK Suture Anchor | Stryker Endoscopy | 2021-08-04 | Traditional | PDF ↗ |
| K211002 | Grappler Suture Anchor System | Paragon 28, Inc. | 2021-07-07 | Traditional | PDF ↗ |
| K202663 | Suture Wing | Osteonic Co., Ltd. | 2021-06-07 | Traditional | PDF ↗ |
| K202763 | Fix2Lock (PEEK Self Punching) | Osteonic Co., Ltd. | 2021-06-04 | Traditional | PDF ↗ |
| K203121 | Responsive Arthroscopy Thunderbolt System | Responsive Arthroscopy, LLC | 2021-04-27 | Traditional | PDF ↗ |
| K203259 | FairFix Adjustable Button System | Medacta International S.A. | 2021-03-26 | Traditional | PDF ↗ |
| K210498 | Betta Link Knotless Implant System | T.A.G. Medical Products Corporation, Ltd. | 2021-03-24 | Special | PDF ↗ |
| K210078 | Stryker ProCinch Adjustable Loop Device | Stryker Endoscopy | 2021-03-11 | Traditional | PDF ↗ |
| K202662 | Parcus Titanium Interference Screws | Parcus Medical, LLC | 2021-02-22 | Traditional | PDF ↗ |
| K203740 | JuggerKnot Soft Anchor | Riverpoint Medical | 2021-02-12 | Traditional | PDF ↗ |
| K203385 | TenoTac Soft Tissue Fixation System | Paragon 28, Inc. | 2021-02-11 | Traditional | PDF ↗ |
| K203794 | HEALIX Ti Dual Threaded Suture Anchor with DYNATAPE Suture | Medos International SARL | 2021-02-01 | Special | PDF ↗ |
| K203485 | SnugFit All-Suture Anchor | Medacta International S.A. | 2021-01-19 | Traditional | PDF ↗ |
| K202291 | Button Loop | Yunyi (Beijing) Medical Device Co., Ltd. | 2021-01-08 | Traditional | PDF ↗ |
| K192709 | Fixone All Suture Anchor | Aju Pharm Co., Ltd. | 2020-12-15 | Traditional | PDF ↗ |
| K203268 | Arthrex FiberTak Suture Anchor | Arthrex, Inc. | 2020-11-27 | Special | PDF ↗ |
| K193377 | TopLock Anchor System | Fusion Orthopedics, LLC | 2020-11-25 | Traditional | PDF ↗ |
| K202883 | Sterile bone screw (PEEK ACL screw) | Osteonic Co., Ltd. | 2020-11-25 | Traditional | PDF ↗ |
| K202444 | Knotless TensionTight Button Implant System | Arthrex, Inc. | 2020-11-17 | Special | PDF ↗ |
| K202355 | Stryker Omega PEEK Knotless Anchor System | Stryker | 2020-11-13 | Traditional | PDF ↗ |
| K202178 | VersaLoop Anchor System | T.A.G. Medical Products Corporation, Ltd. | 2020-11-13 | Traditional | PDF ↗ |
| K193214 | WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System, Biomet Headless Compression and Twist-Off Screws | Biomet, Inc. | 2020-11-10 | Traditional | PDF ↗ |
| K200428 | Multi-Drive Interference Screw System | Nvision Biomedical Technologies, Inc. | 2020-11-10 | Traditional | PDF ↗ |
| K202581 | Arthrex TightRope II | Arthrex, Inc. | 2020-11-04 | Traditional | PDF ↗ |
| K202259 | Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti, Actiflip Naked, Actiflip Cinch, Actiflip Whip, and GFS Ultimate Hip | Parcus Medical, LLC | 2020-10-28 | Traditional | PDF ↗ |
| K202193 | PULLUP BTB Adjustable Fixation System for Ligament Reconstruction, PULLUP CLIP Adjustable Fixation System for Ligament Reconstruction, PULLUP TEX CLIP Adjustable Fixation System for Ligament Reconstruction, BT LOOP Adjustable Fixation System for Ligament Reconstruction | S.B.M. Sas (Science & Bio Materials) | 2020-10-16 | Special | PDF ↗ |
| K192949 | Flower Suture Anchor Set | Flower Orthopedics Corporation | 2020-10-07 | Traditional | PDF ↗ |
| K202399 | OrthoButton FL | Riverpoint Medical | 2020-09-18 | Special | PDF ↗ |
| K202153 | Responsive Arthroscopy Suture Anchor System | Responsive Arthroscopy, LLC | 2020-09-09 | Special | PDF ↗ |
| K200503 | ATL Anchors | International Life Sciences | 2020-09-02 | Traditional | PDF ↗ |
| K201636 | Hercules Suture Anchor System | In2bones USA, LLC | 2020-08-20 | Traditional | PDF ↗ |
| K201883 | 6.5 mm Healix Advance SP Peek Anchor, 6.5 mm Healix Advance SP Biocomposite Anchor | Medos International SARL | 2020-08-07 | Special | PDF ↗ |
| K201083 | Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture Anchors | Parcus Medical, LLC | 2020-07-23 | Traditional | PDF ↗ |
| K200949 | HEALIX ADVANCE Anchor with DYNATAPE Suture | Medos International SARL | 2020-06-04 | Traditional | PDF ↗ |
| K193108 | Bonecam Suture Anchor | Valeris Medical, Inc. | 2020-03-26 | Special | PDF ↗ |
| K200341 | Arthrex FiberTak Suture Anchor | Arthrex, Inc. | 2020-03-12 | Special | PDF ↗ |
| K192810 | Apollo Suture Anchor System | Valeris Medical | 2020-03-11 | Special | PDF ↗ |
| K193402 | ALLthread PEEK Suture Anchor | Biomet, Inc. | 2020-03-05 | Traditional | PDF ↗ |
| K200028 | Coronet Soft Tissue Fixation System | Conextions Medical | 2020-03-04 | Traditional | PDF ↗ |
| K193245 | Dunamis PunchTac Suture Anchors | Dunamis, LLC | 2020-02-14 | Special | PDF ↗ |
| K193165 | MectaFix CL Fixation Button with Continuous Loop | Medacta International S.A. | 2020-02-10 | Traditional | PDF ↗ |
| K193461 | MectaLock All-Suture Anchors | Medacta International S.A. | 2020-02-06 | Traditional | PDF ↗ |
| K191677 | MectaTap TI Suture Anchor | Medacta International S.A. | 2020-01-29 | Traditional | PDF ↗ |
| K191227 | Paratrooper Plantar Plate Repair System | Paragon 28, Inc. | 2020-01-24 | Traditional | PDF ↗ |
| K193295 | Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor | Parcus Medical, LLC | 2020-01-23 | Special | PDF ↗ |
| K193606 | Y-Knot OneStep Anchor | Conmed Corporation | 2020-01-22 | Special | PDF ↗ |
| K192942 | ALLthread Titanium Suture Anchor | Biomet, Inc. | 2020-01-16 | Traditional | PDF ↗ |
| K192750 | AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate Hip | Parcus Medical, LLC | 2020-01-16 | Traditional | PDF ↗ |
Product code MBI · Class II · Orthopedic. Data: openFDA.